Trial Outcomes & Findings for Cardiogenic Shock Intravascular Cooling Trial (NCT NCT03141255)

NCT ID: NCT03141255

Last Updated: 2023-04-12

Results Overview

requiring intervention (medical therapy or therapy with temporary pacemaker)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: up to 96 hours
• Results posted on: 2023-04-12

Participant Flow

Participant milestones

Measure	Control Group Patients will receive only standard of care treatment for cardiogenic shock.	Therapeutic Hypothermia Patients will be cooled to between 32°C and 34°C using the IVTM™ System and the Quattro® Catheter in addition to receiving standard of care treatment for cardiogenic shock. IVTM™ System: TH will be initiated and maintained for 24 hours using the IVTM™ System and the Quattro® Catheter. After 24 hours of maintained TH, patients will be rewarmed to normal body temperature using the same Quattro® Catheter. Quattro® Catheter: TH will be initiated and maintained for 24 hours using the IVTM™ System and the Quattro® Catheter. After 24 hours of maintained TH, patients will be rewarmed to normal body temperature using the same Quattro® Catheter.
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Deviation from the protocol, 2/10 control patients have TTE performed at the base line.

Baseline characteristics by cohort

Measure	Control Group n=10 Participants Patients will receive only standard of care treatment for cardiogenic shock.	Therapeutic Hypothermia n=10 Participants Patients will be cooled to between 32°C and 34°C using the IVTM™ System and the Quattro® Catheter in addition to receiving standard of care treatment for cardiogenic shock. IVTM™ System: TH will be initiated and maintained for 24 hours using the IVTM™ System and the Quattro® Catheter. After 24 hours of maintained TH, patients will be rewarmed to normal body temperature using the same Quattro® Catheter. Quattro® Catheter: TH will be initiated and maintained for 24 hours using the IVTM™ System and the Quattro® Catheter. After 24 hours of maintained TH, patients will be rewarmed to normal body temperature using the same Quattro® Catheter.	Total n=20 Participants Total of all reporting groups
Age, Continuous Age	63.6 years STANDARD_DEVIATION 10.3 • n=10 Participants	62.2 years STANDARD_DEVIATION 10.8 • n=10 Participants	62.9 years STANDARD_DEVIATION 10.3 • n=20 Participants
Sex: Female, Male Female	3 Participants n=10 Participants	3 Participants n=10 Participants	6 Participants n=20 Participants
Sex: Female, Male Male	7 Participants n=10 Participants	7 Participants n=10 Participants	14 Participants n=20 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race (NIH/OMB) Asian	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race (NIH/OMB) Black or African American	6 Participants n=10 Participants	9 Participants n=10 Participants	15 Participants n=20 Participants
Race (NIH/OMB) White	4 Participants n=10 Participants	1 Participants n=10 Participants	5 Participants n=20 Participants
Race (NIH/OMB) More than one race	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Baseline Creatinine	2.1 mg/dL n=10 Participants	2.7 mg/dL n=10 Participants	2.2 mg/dL n=20 Participants
BMI (kg/mg)	31.3 kg/m^2 STANDARD_DEVIATION 6.8 • n=10 Participants	30.1 kg/m^2 STANDARD_DEVIATION 5.4 • n=10 Participants	30.7 kg/m^2 STANDARD_DEVIATION 6.0 • n=20 Participants
Ejection Fraction on initial "TTE"	30.3 percentage of ejection fraction STANDARD_DEVIATION 14.4 • n=10 Participants • Deviation from the protocol, 2/10 control patients have TTE performed at the base line.	34 percentage of ejection fraction STANDARD_DEVIATION 20 • n=10 Participants • Deviation from the protocol, 2/10 control patients have TTE performed at the base line.	32.3 percentage of ejection fraction STANDARD_DEVIATION 17.4 • n=20 Participants • Deviation from the protocol, 2/10 control patients have TTE performed at the base line.
Admission NT-proBNP	15056 pg/mL STANDARD_DEVIATION 11751.4 • n=6 Participants • Deviation from the protocol, 4/10 control patients and 6/10 Therapeutic Hypothermia patients have TTE performed at the base line.	29561.3 pg/mL STANDARD_DEVIATION 26575.1 • n=4 Participants • Deviation from the protocol, 4/10 control patients and 6/10 Therapeutic Hypothermia patients have TTE performed at the base line.	20858.1 pg/mL STANDARD_DEVIATION 19189.6 • n=10 Participants • Deviation from the protocol, 4/10 control patients and 6/10 Therapeutic Hypothermia patients have TTE performed at the base line.
CAD	5 Participants n=10 Participants	6 Participants n=10 Participants	11 Participants n=20 Participants
DM	7 Participants n=10 Participants	6 Participants n=10 Participants	13 Participants n=20 Participants
HTN	10 Participants n=10 Participants	10 Participants n=10 Participants	20 Participants n=20 Participants
CVA	2 Participants n=10 Participants	3 Participants n=10 Participants	5 Participants n=20 Participants
Atrial fibrillation	3 Participants n=10 Participants	2 Participants n=10 Participants	5 Participants n=20 Participants
Beta-blockers	9 Participants n=10 Participants	7 Participants n=10 Participants	16 Participants n=20 Participants
ACEi	5 Participants n=10 Participants	2 Participants n=10 Participants	7 Participants n=20 Participants
ARB	1 Participants n=10 Participants	3 Participants n=10 Participants	4 Participants n=20 Participants
Neprilysin Inhibitor	1 Participants n=10 Participants	2 Participants n=10 Participants	3 Participants n=20 Participants
ASA	7 Participants n=10 Participants	9 Participants n=10 Participants	16 Participants n=20 Participants
Anti-platelet agent	3 Participants n=10 Participants	3 Participants n=10 Participants	6 Participants n=20 Participants
Statin	8 Participants n=10 Participants	7 Participants n=10 Participants	15 Participants n=20 Participants
Diuretic	7 Participants n=10 Participants	7 Participants n=10 Participants	14 Participants n=20 Participants
Antiarrhythmic	1 Participants n=10 Participants	1 Participants n=10 Participants	2 Participants n=20 Participants
Inotropic support prior to enrollment	2 Participants n=10 Participants	0 Participants n=10 Participants	2 Participants n=20 Participants
Mechanical Circulatory Support prior to enrollment	6 Participants n=10 Participants	3 Participants n=10 Participants	9 Participants n=20 Participants
IABP	6 Participants n=10 Participants	3 Participants n=10 Participants	9 Participants n=20 Participants
ACS	4 Participants n=10 Participants	1 Participants n=10 Participants	5 Participants n=20 Participants
Acute on Chronic ICM/NICM	7 Participants n=10 Participants	8 Participants n=10 Participants	15 Participants n=20 Participants
Mechanical Ventilation	7 Participants n=10 Participants	3 Participants n=10 Participants	10 Participants n=20 Participants

PRIMARY outcome

Timeframe: up to 96 hours

requiring intervention (medical therapy or therapy with temporary pacemaker)

Outcome measures

Measure	Control n=10 Participants Patients will receive only standard of care treatment for cardiogenic shock.	Therapeutic Hypothermia n=10 Participants Patients will be cooled to between 32°C and 34°C using the IVTM™ System and the Quattro® Catheter in addition to receiving standard of care treatment for cardiogenic shock. IVTM™ System: TH will be initiated and maintained for 24 hours using the IVTM™ System and the Quattro® Catheter. After 24 hours of maintained TH, patients will be rewarmed to normal body temperature using the same Quattro® Catheter. Quattro® Catheter: TH will be initiated and maintained for 24 hours using the IVTM™ System and the Quattro® Catheter. After 24 hours of maintained TH, patients will be rewarmed to normal body temperature using the same Quattro® Catheter.
Number of Participants With Episodes of Arrhythmia	0 Participants	1 Participants

PRIMARY outcome

Timeframe: up to 96 hours

requiring transfusions as a direct result of the cooling catheter insertion or secondary to resulting coagulopathy

Outcome measures

Measure	Control n=10 Participants Patients will receive only standard of care treatment for cardiogenic shock.	Therapeutic Hypothermia n=10 Participants Patients will be cooled to between 32°C and 34°C using the IVTM™ System and the Quattro® Catheter in addition to receiving standard of care treatment for cardiogenic shock. IVTM™ System: TH will be initiated and maintained for 24 hours using the IVTM™ System and the Quattro® Catheter. After 24 hours of maintained TH, patients will be rewarmed to normal body temperature using the same Quattro® Catheter. Quattro® Catheter: TH will be initiated and maintained for 24 hours using the IVTM™ System and the Quattro® Catheter. After 24 hours of maintained TH, patients will be rewarmed to normal body temperature using the same Quattro® Catheter.
Number of Participants With Bleeding	0 Participants	2 Participants

PRIMARY outcome

Timeframe: up to 96 hours

confirmed with 2 positive blood cultures or sequential organ failure assessment (SOFA) score >2

Outcome measures

Measure	Control n=10 Participants Patients will receive only standard of care treatment for cardiogenic shock.	Therapeutic Hypothermia n=10 Participants Patients will be cooled to between 32°C and 34°C using the IVTM™ System and the Quattro® Catheter in addition to receiving standard of care treatment for cardiogenic shock. IVTM™ System: TH will be initiated and maintained for 24 hours using the IVTM™ System and the Quattro® Catheter. After 24 hours of maintained TH, patients will be rewarmed to normal body temperature using the same Quattro® Catheter. Quattro® Catheter: TH will be initiated and maintained for 24 hours using the IVTM™ System and the Quattro® Catheter. After 24 hours of maintained TH, patients will be rewarmed to normal body temperature using the same Quattro® Catheter.
Number of Participants With Bloodstream Infection/Suspected Sepsis	0 Participants	0 Participants

PRIMARY outcome

Timeframe: up to 96 hours

potassium levels below 3.0mEq/L, not secondary to other identifiable causes

Outcome measures

Measure	Control n=10 Participants Patients will receive only standard of care treatment for cardiogenic shock.	Therapeutic Hypothermia n=10 Participants Patients will be cooled to between 32°C and 34°C using the IVTM™ System and the Quattro® Catheter in addition to receiving standard of care treatment for cardiogenic shock. IVTM™ System: TH will be initiated and maintained for 24 hours using the IVTM™ System and the Quattro® Catheter. After 24 hours of maintained TH, patients will be rewarmed to normal body temperature using the same Quattro® Catheter. Quattro® Catheter: TH will be initiated and maintained for 24 hours using the IVTM™ System and the Quattro® Catheter. After 24 hours of maintained TH, patients will be rewarmed to normal body temperature using the same Quattro® Catheter.
Number of Participants With Hypokalemia	0 Participants	0 Participants

SECONDARY outcome

Timeframe: up to 96 hours

Difference between groups in cardiac index and output

Outcome measures

Measure	Control n=10 Participants Patients will receive only standard of care treatment for cardiogenic shock.	Therapeutic Hypothermia n=10 Participants Patients will be cooled to between 32°C and 34°C using the IVTM™ System and the Quattro® Catheter in addition to receiving standard of care treatment for cardiogenic shock. IVTM™ System: TH will be initiated and maintained for 24 hours using the IVTM™ System and the Quattro® Catheter. After 24 hours of maintained TH, patients will be rewarmed to normal body temperature using the same Quattro® Catheter. Quattro® Catheter: TH will be initiated and maintained for 24 hours using the IVTM™ System and the Quattro® Catheter. After 24 hours of maintained TH, patients will be rewarmed to normal body temperature using the same Quattro® Catheter.
Changes in Cardiac Index	2.6 Liter/minute/m^2 Interval 2.5 to 3.15	3.6 Liter/minute/m^2 Interval 3.1 to 3.9

SECONDARY outcome

Timeframe: up to 96 hours

Mean SVR in population

Outcome measures

Measure	Control n=10 Participants Patients will receive only standard of care treatment for cardiogenic shock.	Therapeutic Hypothermia n=10 Participants Patients will be cooled to between 32°C and 34°C using the IVTM™ System and the Quattro® Catheter in addition to receiving standard of care treatment for cardiogenic shock. IVTM™ System: TH will be initiated and maintained for 24 hours using the IVTM™ System and the Quattro® Catheter. After 24 hours of maintained TH, patients will be rewarmed to normal body temperature using the same Quattro® Catheter. Quattro® Catheter: TH will be initiated and maintained for 24 hours using the IVTM™ System and the Quattro® Catheter. After 24 hours of maintained TH, patients will be rewarmed to normal body temperature using the same Quattro® Catheter.
Changes in Systemic Vascular Resistance (SVR)	965 mm Hg*min/mL Interval 891.0 to 1051.0	702 mm Hg*min/mL Interval 667.0 to 827.0

SECONDARY outcome

Timeframe: up to 96 hours

Measured 48-96 hours after randomization

Outcome measures

Measure	Control n=10 Participants Patients will receive only standard of care treatment for cardiogenic shock.	Therapeutic Hypothermia n=10 Participants Patients will be cooled to between 32°C and 34°C using the IVTM™ System and the Quattro® Catheter in addition to receiving standard of care treatment for cardiogenic shock. IVTM™ System: TH will be initiated and maintained for 24 hours using the IVTM™ System and the Quattro® Catheter. After 24 hours of maintained TH, patients will be rewarmed to normal body temperature using the same Quattro® Catheter. Quattro® Catheter: TH will be initiated and maintained for 24 hours using the IVTM™ System and the Quattro® Catheter. After 24 hours of maintained TH, patients will be rewarmed to normal body temperature using the same Quattro® Catheter.
Cardiac Power Index	0.61 W/m^2 Interval 0.55 to 0.7	0.53 W/m^2 Interval 0.435 to 0.565

SECONDARY outcome

Timeframe: up to 96 hours

cumulative weight adjusted dosing of milrinone

Outcome measures

Measure	Control n=10 Participants Patients will receive only standard of care treatment for cardiogenic shock.	Therapeutic Hypothermia n=10 Participants Patients will be cooled to between 32°C and 34°C using the IVTM™ System and the Quattro® Catheter in addition to receiving standard of care treatment for cardiogenic shock. IVTM™ System: TH will be initiated and maintained for 24 hours using the IVTM™ System and the Quattro® Catheter. After 24 hours of maintained TH, patients will be rewarmed to normal body temperature using the same Quattro® Catheter. Quattro® Catheter: TH will be initiated and maintained for 24 hours using the IVTM™ System and the Quattro® Catheter. After 24 hours of maintained TH, patients will be rewarmed to normal body temperature using the same Quattro® Catheter.
Cumulative Milrinone Dose	0.28 mg/kg Interval 0.0 to 0.578	0.36 mg/kg Interval 0.0 to 0.52

SECONDARY outcome

Timeframe: up to 18-24 hours

percent ejection fraction on echocardiogram at 18-24 hours after randomization

Outcome measures

Measure	Control n=10 Participants Patients will receive only standard of care treatment for cardiogenic shock.	Therapeutic Hypothermia n=10 Participants Patients will be cooled to between 32°C and 34°C using the IVTM™ System and the Quattro® Catheter in addition to receiving standard of care treatment for cardiogenic shock. IVTM™ System: TH will be initiated and maintained for 24 hours using the IVTM™ System and the Quattro® Catheter. After 24 hours of maintained TH, patients will be rewarmed to normal body temperature using the same Quattro® Catheter. Quattro® Catheter: TH will be initiated and maintained for 24 hours using the IVTM™ System and the Quattro® Catheter. After 24 hours of maintained TH, patients will be rewarmed to normal body temperature using the same Quattro® Catheter.
Left Ventricular Ejection Fraction	40.1 percent Interval 36.2 to 40.8	28.1 percent Interval 22.4 to 62.5

SECONDARY outcome

Timeframe: up to 96 hours, 30 days, and 90 days

All-cause mortality at 90 days was primary outcome/time point of choice.

Outcome measures

Measure	Control n=10 Participants Patients will receive only standard of care treatment for cardiogenic shock.	Therapeutic Hypothermia n=10 Participants Patients will be cooled to between 32°C and 34°C using the IVTM™ System and the Quattro® Catheter in addition to receiving standard of care treatment for cardiogenic shock. IVTM™ System: TH will be initiated and maintained for 24 hours using the IVTM™ System and the Quattro® Catheter. After 24 hours of maintained TH, patients will be rewarmed to normal body temperature using the same Quattro® Catheter. Quattro® Catheter: TH will be initiated and maintained for 24 hours using the IVTM™ System and the Quattro® Catheter. After 24 hours of maintained TH, patients will be rewarmed to normal body temperature using the same Quattro® Catheter.
All-cause Mortality	3 Participants	4 Participants

SECONDARY outcome

Timeframe: 96 hours

Population: All trial participants

Cumulative dose of weight adjusted dobutamine dobutamine

Outcome measures

Measure	Control n=10 Participants Patients will receive only standard of care treatment for cardiogenic shock.	Therapeutic Hypothermia n=10 Participants Patients will be cooled to between 32°C and 34°C using the IVTM™ System and the Quattro® Catheter in addition to receiving standard of care treatment for cardiogenic shock. IVTM™ System: TH will be initiated and maintained for 24 hours using the IVTM™ System and the Quattro® Catheter. After 24 hours of maintained TH, patients will be rewarmed to normal body temperature using the same Quattro® Catheter. Quattro® Catheter: TH will be initiated and maintained for 24 hours using the IVTM™ System and the Quattro® Catheter. After 24 hours of maintained TH, patients will be rewarmed to normal body temperature using the same Quattro® Catheter.
Cumulative Dobutamine Dose	0 mg/kg Interval 0.0 to 1.6	0 mg/kg Interval 0.0 to 10.75

SECONDARY outcome

Timeframe: 96 hours

Population: All patients in study were analyzed

Cumulative weight adjusted dopamine dose

Outcome measures

Measure	Control n=10 Participants Patients will receive only standard of care treatment for cardiogenic shock.	Therapeutic Hypothermia n=10 Participants Patients will be cooled to between 32°C and 34°C using the IVTM™ System and the Quattro® Catheter in addition to receiving standard of care treatment for cardiogenic shock. IVTM™ System: TH will be initiated and maintained for 24 hours using the IVTM™ System and the Quattro® Catheter. After 24 hours of maintained TH, patients will be rewarmed to normal body temperature using the same Quattro® Catheter. Quattro® Catheter: TH will be initiated and maintained for 24 hours using the IVTM™ System and the Quattro® Catheter. After 24 hours of maintained TH, patients will be rewarmed to normal body temperature using the same Quattro® Catheter.
Cumulative Dopamine Dose	0 mg/kg Interval 0.0 to 0.23	7.27 mg/kg Interval 0.0 to 35.28

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Therapeutic Hypothermia

Serious events: 1 serious events

Other events: 8 other events

Deaths: 4 deaths

Serious adverse events

Measure	Control Group n=10 participants at risk Patients will receive only standard of care treatment for cardiogenic shock.	Therapeutic Hypothermia n=10 participants at risk Patients will be cooled to between 32°C and 34°C using the IVTM™ System and the Quattro® Catheter in addition to receiving standard of care treatment for cardiogenic shock. IVTM™ System: TH will be initiated and maintained for 24 hours using the IVTM™ System and the Quattro® Catheter. After 24 hours of maintained TH, patients will be rewarmed to normal body temperature using the same Quattro® Catheter. Quattro® Catheter: TH will be initiated and maintained for 24 hours using the IVTM™ System and the Quattro® Catheter. After 24 hours of maintained TH, patients will be rewarmed to normal body temperature using the same Quattro® Catheter.
General disorders Bradycardic Arrest	0.00% 0/10 • 90 days Adverse events were systematically collected and analyzed for these inpatient clinical trial participants. Changes in vitals, clinical condition, need for transfusions, and other events were reported by managing team to trial coordinators. Each relevant event was discussed with the data safety monitoring board.	10.0% 1/10 • Number of events 1 • 90 days Adverse events were systematically collected and analyzed for these inpatient clinical trial participants. Changes in vitals, clinical condition, need for transfusions, and other events were reported by managing team to trial coordinators. Each relevant event was discussed with the data safety monitoring board.

Other adverse events

Measure	Control Group n=10 participants at risk Patients will receive only standard of care treatment for cardiogenic shock.	Therapeutic Hypothermia n=10 participants at risk Patients will be cooled to between 32°C and 34°C using the IVTM™ System and the Quattro® Catheter in addition to receiving standard of care treatment for cardiogenic shock. IVTM™ System: TH will be initiated and maintained for 24 hours using the IVTM™ System and the Quattro® Catheter. After 24 hours of maintained TH, patients will be rewarmed to normal body temperature using the same Quattro® Catheter. Quattro® Catheter: TH will be initiated and maintained for 24 hours using the IVTM™ System and the Quattro® Catheter. After 24 hours of maintained TH, patients will be rewarmed to normal body temperature using the same Quattro® Catheter.
Blood and lymphatic system disorders Bleeding	0.00% 0/10 • 90 days Adverse events were systematically collected and analyzed for these inpatient clinical trial participants. Changes in vitals, clinical condition, need for transfusions, and other events were reported by managing team to trial coordinators. Each relevant event was discussed with the data safety monitoring board.	20.0% 2/10 • Number of events 2 • 90 days Adverse events were systematically collected and analyzed for these inpatient clinical trial participants. Changes in vitals, clinical condition, need for transfusions, and other events were reported by managing team to trial coordinators. Each relevant event was discussed with the data safety monitoring board.
Cardiac disorders Bradycardia	0.00% 0/10 • 90 days Adverse events were systematically collected and analyzed for these inpatient clinical trial participants. Changes in vitals, clinical condition, need for transfusions, and other events were reported by managing team to trial coordinators. Each relevant event was discussed with the data safety monitoring board.	10.0% 1/10 • Number of events 1 • 90 days Adverse events were systematically collected and analyzed for these inpatient clinical trial participants. Changes in vitals, clinical condition, need for transfusions, and other events were reported by managing team to trial coordinators. Each relevant event was discussed with the data safety monitoring board.
Endocrine disorders Hyperglycemia	0.00% 0/10 • 90 days Adverse events were systematically collected and analyzed for these inpatient clinical trial participants. Changes in vitals, clinical condition, need for transfusions, and other events were reported by managing team to trial coordinators. Each relevant event was discussed with the data safety monitoring board.	10.0% 1/10 • Number of events 1 • 90 days Adverse events were systematically collected and analyzed for these inpatient clinical trial participants. Changes in vitals, clinical condition, need for transfusions, and other events were reported by managing team to trial coordinators. Each relevant event was discussed with the data safety monitoring board.
Cardiac disorders Hypotension	0.00% 0/10 • 90 days Adverse events were systematically collected and analyzed for these inpatient clinical trial participants. Changes in vitals, clinical condition, need for transfusions, and other events were reported by managing team to trial coordinators. Each relevant event was discussed with the data safety monitoring board.	10.0% 1/10 • Number of events 1 • 90 days Adverse events were systematically collected and analyzed for these inpatient clinical trial participants. Changes in vitals, clinical condition, need for transfusions, and other events were reported by managing team to trial coordinators. Each relevant event was discussed with the data safety monitoring board.
Cardiac disorders Non-sustained Ventricular Tachycardia	0.00% 0/10 • 90 days Adverse events were systematically collected and analyzed for these inpatient clinical trial participants. Changes in vitals, clinical condition, need for transfusions, and other events were reported by managing team to trial coordinators. Each relevant event was discussed with the data safety monitoring board.	10.0% 1/10 • Number of events 1 • 90 days Adverse events were systematically collected and analyzed for these inpatient clinical trial participants. Changes in vitals, clinical condition, need for transfusions, and other events were reported by managing team to trial coordinators. Each relevant event was discussed with the data safety monitoring board.
General disorders Shivering	0.00% 0/10 • 90 days Adverse events were systematically collected and analyzed for these inpatient clinical trial participants. Changes in vitals, clinical condition, need for transfusions, and other events were reported by managing team to trial coordinators. Each relevant event was discussed with the data safety monitoring board.	20.0% 2/10 • Number of events 2 • 90 days Adverse events were systematically collected and analyzed for these inpatient clinical trial participants. Changes in vitals, clinical condition, need for transfusions, and other events were reported by managing team to trial coordinators. Each relevant event was discussed with the data safety monitoring board.
Respiratory, thoracic and mediastinal disorders Aspiration Event	0.00% 0/10 • 90 days Adverse events were systematically collected and analyzed for these inpatient clinical trial participants. Changes in vitals, clinical condition, need for transfusions, and other events were reported by managing team to trial coordinators. Each relevant event was discussed with the data safety monitoring board.	10.0% 1/10 • Number of events 1 • 90 days Adverse events were systematically collected and analyzed for these inpatient clinical trial participants. Changes in vitals, clinical condition, need for transfusions, and other events were reported by managing team to trial coordinators. Each relevant event was discussed with the data safety monitoring board.

Additional Information

Jonathan D. Paul, MD

The University of Chicago

Phone: (773) 702-9461

Email: jpaul@bsd.uchicago.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place